{ "FullStudy":{ "Rank":218120, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512472", "OrgStudyIdInfo":{ "OrgStudyId":"CURC - FIT-0002" }, "Organization":{ "OrgFullName":"Canadian Urology Research Consortium", "OrgClass":"OTHER" }, "BriefTitle":"Firmagon (Degarelix) Intermittent Therapy", "OfficialTitle":"Randomized, Multicentre Efficacy and Safety Study Comparing 10 Mons vs 4 Mons Degarelix Therapy in Prolonging the Off Treatment Interval in Men With Localized Prostate Cancer Receiving Intermittent ADT for Biochemical Recurrence Following Radical Local Therapy", "Acronym":"FIT" }, "StatusModule":{ "StatusVerifiedDate":"September 2019", "OverallStatus":"Terminated", "WhyStopped":"acrrual target was not being met", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2018", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"November 10, 2011", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 19, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 23, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Canadian Urology Research Consortium", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Ferring Pharmaceuticals", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.", "DetailedDescription":"This is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot. All patients will be treated with a one-month starting dose of 240mg on Day 0. Subjects are then randomized to receive either nine or three maintenance doses of one month duration. The primary objective is to determine the effect of degarelix therapy on the length of the off treatment interval (defined as serum Prostate-specific antigen (PSA) increasing to 5 ng/ml) following completion of the androgen deprivation therapy. The trial will also assess the effect of degarelix therapy on PSA kinetics (specifically PSA doubling time), PSA nadir, and effect on quality of life as well as other measures. The efficacy and safety of these two treatments will also be reported." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Prostate Cancer Recurrent" ] }, "KeywordList":{ "Keyword":[ "localized prostate cancer", "degarelix", "intermittent androgen deprivation therapy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"144", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"10 month degarelix therapy", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: degarelix" ] } },{ "ArmGroupLabel":"4 month degarelix therapy arm", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: degarelix" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"degarelix", "InterventionDescription":"Starting dose of 240 mg (40 mg/mL; injection volume 2 x 3 mL; s.c.) degarelix one-month depot will be administered sc on Day 0, followed by a maintenance dose of 80 mg (20 mg/mL; injection volume 1 x 4 mL; s.c.) sc degarelix one-month depot will be administered into the anterior abdominal wall on Month 1, 2, 3, 4, 5, 6, 7, 8 and 9 for the 10 month arm and month 1, 2 and 3 for the 4 month arm.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "10 month degarelix therapy", "4 month degarelix therapy arm" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"serum PSA", "PrimaryOutcomeDescription":"The study will compare the length of the off treatment interval (in months) of subjects in the 4 month arm vs those in the 10 month arm. The off treatment interval is defined as the time from PSA nadir following completion of hormone therapy in both arms until the time PSA reaches 5.0ng/ml", "PrimaryOutcomeTimeFrame":"approximately 15 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"serum PSA", "SecondaryOutcomeDescription":"PSA nadir is described as the serum PSA value after the completion of either 4 months or 10 months of therapy.", "SecondaryOutcomeTimeFrame":"at 4 months (4 mon arm) or 10 montths (10 mon arm)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nhistologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated\nPSA level meeting both of these criteria:\nPSA level of ≥ 5 ng/mL.\nFor patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir.\nscreening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL.\n\nExclusion Criteria:\n\nHas had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)\nHas received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening", "HealthyVolunteers":"No", "Gender":"Male", "MinimumAge":"18 Years", "MaximumAge":"85 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Laurence Klotz, MD", "OverallOfficialAffiliation":"Canadian Urology Research Consortium", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"The Prostate Centre", "LocationCity":"Vancouver", "LocationState":"British Columbia", "LocationZip":"V6Z 3J5", "LocationCountry":"Canada" },{ "LocationFacility":"Manitoba Prostate Centre", "LocationCity":"Winnipeg", "LocationState":"Manitoba", "LocationZip":"R3E 0V9", "LocationCountry":"Canada" },{ "LocationFacility":"Centre of Clinical Research", "LocationCity":"Halifax", "LocationState":"Nova Scotia", "LocationZip":"B3H 1V7", "LocationCountry":"Canada" },{ "LocationFacility":"McMaster Institute of Urology", "LocationCity":"Hamilton", "LocationState":"Ontario", "LocationZip":"L8N 4A6", "LocationCountry":"Canada" },{ "LocationFacility":"Centre of Applied Urological Research / Kingston General Hospital", "LocationCity":"Kingston", "LocationState":"Ontario", "LocationZip":"K7L 3J7", "LocationCountry":"Canada" },{ "LocationFacility":"London Health Sciences Centre", "LocationCity":"London", "LocationState":"Ontario", "LocationZip":"N6A 5W9", "LocationCountry":"Canada" },{ "LocationFacility":"URLX Corporation", "LocationCity":"Ottawa", "LocationState":"Ontario", "LocationZip":"K1H 1A2", "LocationCountry":"Canada" },{ "LocationFacility":"Northeast Cancer Centre, Health Sciences North", "LocationCity":"Sudbury", "LocationState":"Ontario", "LocationZip":"P3E 5J1", "LocationCountry":"Canada" },{ "LocationFacility":"Sunnybrook Health Sciences Centre", "LocationCity":"Toronto", "LocationState":"Ontario", "LocationZip":"M4N 3M5", "LocationCountry":"Canada" },{ "LocationFacility":"University Health Network", "LocationCity":"Toronto", "LocationState":"Ontario", "LocationZip":"M5G 2M9", "LocationCountry":"Canada" },{ "LocationFacility":"Recherches Clinique /Clinical Research", "LocationCity":"Granby", "LocationState":"Quebec", "LocationZip":"J2G 8Z9", "LocationCountry":"Canada" },{ "LocationFacility":"The Urology Specialists / Les Urologues Specialises", "LocationCity":"Montreal", "LocationState":"Quebec", "LocationZip":"H2X 1N8", "LocationCountry":"Canada" },{ "LocationFacility":"MUHC Montreal General Hospital", "LocationCity":"Montreal", "LocationState":"Quebec", "LocationZip":"H3G 1A4", "LocationCountry":"Canada" },{ "LocationFacility":"Ultra-Med Research", "LocationCity":"Pointe Claire", "LocationState":"Quebec", "LocationZip":"H9R 4S3", "LocationCountry":"Canada" },{ "LocationFacility":"Centre de recherche du CHUQ-L'hotel-Dieu de Quebec", "LocationCity":"Quebec", "LocationZip":"G1R 3S1", "LocationCountry":"Canada" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000011471", "ConditionMeshTerm":"Prostatic Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000005834", "ConditionAncestorTerm":"Genital Neoplasms, Male" },{ "ConditionAncestorId":"D000014565", "ConditionAncestorTerm":"Urogenital Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000005832", "ConditionAncestorTerm":"Genital Diseases, Male" },{ "ConditionAncestorId":"D000011469", "ConditionAncestorTerm":"Prostatic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M12918", "ConditionBrowseLeafName":"Prostatic Neoplasms", "ConditionBrowseLeafAsFound":"Prostate Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13433", "ConditionBrowseLeafName":"Recurrence", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7529", "ConditionBrowseLeafName":"Genital Neoplasms, Male", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15898", "ConditionBrowseLeafName":"Urogenital Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7527", "ConditionBrowseLeafName":"Genital Diseases, Male", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12916", "ConditionBrowseLeafName":"Prostatic Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }